California permits stem cell practice subject to mandatory FDA-status disclosure.
Statute
CA SB 512 (2017), SB 1495 (2018)
Effective
Effective 2017, amended 2018
California requires healthcare providers to alert patients that stem cell interventions they receive are not FDA-approved, and SB 1495 modified informed consent requirements while mandating annual reporting by the Medical Board. Practice is permitted; transparency is required.
The requirements below are set by CA SB 512 (2017), SB 1495 (2018). Compliance is the responsibility of each individual treating physician under their state license.
Statutory compliance does not equal FDA approval. The procedures discussed are investigational and have not been approved by the US Food and Drug Administration.
California has enacted CA SB 512 (2017), SB 1495 (2018), which sets out specific conditions under which a state-licensed physician may practice in this area. The procedures discussed here are investigational and have not been approved by the US Food and Drug Administration.
No. Adults may travel to California from any US state for an in-person consultation with a network physician. Whether any procedure is appropriate is a clinical decision determined by the treating physician.
Cost depends on the indication, the cell product, and the treating physician. Each physician sets their own pricing and provides a written estimate. Select Stem Cell does not collect medical fees on behalf of physicians.
Yes. California law requires the treating physician to provide written disclosure of investigational status and obtain informed consent prior to any procedure.
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